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Re: Maddog720 post# 15057

Friday, 05/07/2010 11:13:36 AM

Friday, May 07, 2010 11:13:36 AM

Post# of 59549
Thanks Maddog. It sounds like one of the posters on this board was right when he said the thinks the FDA team is having some difficulty understanding the device. Still, I don't think a PMA is anywhere near appropriate in this case. With quality images and a good safety profile we should be in the clear here.